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PEMAZYRE pemigatinib 4.5 mg tablet blister pack - TGA Drug Approval Details
Approvals
/
TGA
/
PEMAZYRE pemigatinib 4.5 mg tablet blister pack
Approved
STANDARD
PEMAZYRE pemigatinib 4.5 mg tablet blister pack
Specialised Therapeutics Alim Pty Ltd
🇦🇺 Therapeutic Goods Administration
Approval Date
May 29, 2025
Approval ID
05a659dd72e0a541
Company
Specialised Therapeutics Alim Pty Ltd
Type
Standard
Approval Details
Approval Id
05a659dd72e0a541
Product Name
PEMAZYRE pemigatinib 4.5 mg tablet blister pack
Artg Id
375309
Artg Name
PEMAZYRE pemigatinib 4.5 mg tablet blister pack
Sponsor
Specialised Therapeutics Alim Pty Ltd
Company Detail Path
/organization/specialised-therapeutics-alim-pty-ltd
Artg Date
2022-09-14
Registration Type
Medicine
Therapeutic Good Type
Medicine
Licence Status
A
Licence Category
REP
Consumer Medicine Info
https://medical-cdn.nocode.com/drug_tga/32a93cdf9068d0e3b8da9f394f2ac542.pdf
Product Information
https://medical-cdn.nocode.com/drug_tga/db3d793ed614b62e0d4514bb45855cbe.pdf
Active Ingredients
Approved
Quick Info
Agency
TGA
Country
🇦🇺
Approval Date
May 29, 2025
Approval ID
05a659dd72e0a541
Type
Standard
Back to TGA Approvals